¿ Amylin Pharmaceuticals Inc., of San Diego, and Alkermes Inc., of Cambridge, Mass., reported results from an initial safety study in healthy volunteers designed to investigate multiple long-acting release (LAR) formulations of Amylin¿s drug candidate, AC2993 (synthetic exendin-4). Sustained plasma concentrations of AC2993 were measured for greater than 30 days in all formulations tested and AC2993 LAR was well tolerated. The formulations of AC2993 in this study are based on Alkermes¿ patented Medisorb injectable sustained-release drug delivery technology and are being developed by Amylin as a potential treatment for Type II diabetes.
¿ BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said, following discussions with the FDA, it is preparing to move forward in the United States and complete a Phase III trial of RWJ-270201, originally initiated February 2000 in Europe. The trial was delayed because the FDA imposed more monitoring requirements. The multicenter trial will administer RWJ-270201 once daily orally to treat viral influenza in patients during the 2001-2002 flu season. BioCryst, at the time of the delay, maintained it would restart the trial when appropriate. The company¿s stock (NASDAQ:BRCX) closed Monday at $4.23, up 18 cents. (See BioWorld Today, Feb. 9, 2000, and Dec. 27, 2000.)
¿ Bioxel Pharma Inc., of Sainte-Foy, Quebec, said its shares began trading on the Canadian Venture Exchange under the ticker symbol BIP Monday. Bioxel focuses on developing, manufacturing and marketing naturally derived taxanes, substances isolated from natural sources.
¿ Cepheid Inc., of Sunnyvale, Calif., and Environmental Technologies Group Inc., of Baltimore, Md., formed a collaboration to develop biological-agent detection systems for military and other domestic preparedness applications. The companies will develop and design bio-detection systems based on Cepheid¿s technologies for the capture, purification, amplification and detection of DNA. Cepheid¿s I-Core and microfluidic technologies will be key components of the DNA detection systems that will be manufactured and marketed on a worldwide basis by ETG and its sister company, Graseby Dynamics Ltd., under royalty bearing licenses from Cepheid. Financial terms were not disclosed.
¿ Collateral Therapeutics Inc., of San Diego, received a $4 million payment from its development partner, Schering AG, of Berlin, for the clinical advancement of Collateral¿s nonsurgical angiogenic gene therapy technologies, Generx and Genvascor. Generx has potential to treat stable exertional angina due to coronary artery disease and is advancing to PhaseIIb/III pivotal trials in the United States and Europe. Genvascor is designed to treat peripheral vascular disease and is advancing from preclinical status to Phase I/II clinical trials in Europe. Either Schering AG or its affiliates will be responsible for conducting and financing these trials.
¿ Curis Inc., of Cambridge, Mass., and Aegera Therapeutics Inc., of Montreal, Quebec, reported publication in the journal Nature Cell Biology of what they termed ¿a breakthrough technique in stem cell research using adult human skin.¿ According to Curis, findings by professor Freda Miller at McGill University¿s Montreal Neurological Institute confirm the company¿s hypothesis that stem cells present in adult skin ¿may be able to give rise to a variety of cell types that go beyond their tissue of origin.¿ Curis said the focus of the collaboration with Aegera is diabetes, neurology and cardiovascular medicine.
¿ Enzon Inc., of Piscataway, N.J., said Schering-Plough Corp., of Madison, N.J., reported it entered a licensing agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and Hoffmann-La Roche Inc. that settles all patent disputes relative to the two companies¿ respective peginterferon products. Financial terms of the agreement were not disclosed. The agreement is subject to the court¿s dismissal of the relevant lawsuits.
¿ Forbes Medi-Tech Inc., of Vancouver, British Columbia, and the University of British Columbia were awarded an approximate $280,000 collaborative research grant from the Canadian Institutes of Health Research to study the mechanism of action of sterol-based pharmaceuticals on cholesterol absorption with a focus on Forbes¿ phytosterol analogue, FM-VP4, and related compounds. The primary focus of the estimated three-year research project, which is expected to have a total cost of up to $1 million, is to identify the mechanisms of action by which phytosterols and phytosterol analogues inhibit cholesterol absorption and help prevent cardiovascular disease.
¿ Gene Logic Inc., of Gaithersburg, Md., launched a GeneExpress Suite product, the GeneExpress Human Atlas DataSuite, a survey of normal human gene expression and is a baseline reference source with direct application in therapeutic target screening and prioritization, the company said.
¿ Genzyme Canada Inc., of Mississauga, Ontario, signed a three-year exclusive agreement with Theramed Corp., a subsidiary of Meta Health Services Inc., of Vancouver, British Columbia, to jointly market Genzyme¿s Thyrogen (thyrotropin alfa for injection) recombinant thyroid-stimulating hormone following Canadian regulatory approval, anticipated during the fourth quarter of this year. Theramed, which will receive royalties based on predetermined sales levels, is a marketer of thyroid medications to Canadian endocrinologists. The proposed indication for Thyrogen is for use in evaluating patients for thyroid cancer metastases. Genzyme Canada is a wholly owned subsidiary of Cambridge, Mass.-based Genzyme Corp.
¿ Geron Corp., of Menlo Park, Calif., said Kyowa Hakko Kogyo Co. Ltd., of Tokyo, selected a telomerase inhibitor compound, GRN163, for development as an anticancer drug. The compound is a short, modified oligonucleotide designed as a telomerase template antagonist. In vivo studies in rodents demonstrated activity against human malignant glioblastoma. Kyowa has marketing rights for certain Asian countries. Geron otherwise holds worldwide rights.
¿ GlycoDesign Inc. said it will collaborate with Brigham and Women¿s Hospital of Boston in a research effort involving a form of CD44, called CD44-HCELL, found on human bone marrow stem cells. Robert Sackstein of Harvard Medical School said one major goal of the research is to develop reagents that can be used to treat patients with blood diseases and improve the recovery of patients following bone marrow transplants. Toronto-based GlycoDesign has the right to negotiate worldwide licenses to all therapeutic and diagnostic inventions arising out of the research.
¿ Hybrigenics SA, of Paris, said its computational approach for predicting cellular protein interactions across whole organisms, called the Interaction-Domain Pair Profile method, was presented at the 9th International Conference of Intelligent Systems for Molecular Biology in Copenhagen, Denmark. The method allows researchers to predict the interaction map of a target organism based on the analysis of a similar map determined experimentally.
¿ IGEN International Inc., of Gaithersburg, Md., said the U.S. District Court of the District of Maryland court ruled, among other things, that Roche Diagnostics, a division of F. Hoffmann-La Roche Ltd., of Basel, Switzerland, breached a licensing agreement with IGEN by settling a patent infringement suit with a third party without IGEN¿s consent and failing to cease development of a competing product line. Also, the court accepted IGEN¿s legal positions on counts concerning IGEN¿s allegations that Roche sold products outside the licensed field and that it failed to ensure its affiliates comply with the agreement.
¿ Immunex Corp., of Seattle, and Wyeth-Ayerst Laboratories, a division of American Home Products Corp., of Madison, N.J., will sponsor a 10,000-patient rheumatoid arthritis study, titled RADIUS (Rheumatoid Arthritis DMARD Intervention and Utilization Study) is designed to gain knowledge on current treatment. An independent advisory board of academic and community-based rheumatologists will evaluate and interpret data collected in the study. The study will be evenly split into RADIUS 1 and RADIUS 2. RADIUS 1 will enroll patients needing new disease modifying anti-rheumatic drugs, or an addition to or change to current treatment. The trial is expected to begin in late summer. RADIUS 2 patients will begin a new treatment with Enbrel. The trial is expected to begin in 2002 when additional supplies of Enbrel become available. Enbrel was approved for rheumatoid arthritis in November 1998. (See BioWorld Today, Nov. 3, 1998.)
¿ Inex Pharmaceuticals Corp., of Vancouver, British Columbia, said that an independent data safety monitoring board reviewed safety data for about 35 patients in its pivotal Phase II/III trial for its lead product, Onco TCS, as a treatment for relapsed aggressive non-Hodgkin¿s lymphoma. The board recommended Inex continue the trial without any modifications. The review was prospectively specified in the original protocol. The trial is designed to support a regulatory filing under accelerated development and fast track designations in late 2002 or early 2003.
¿ Invitrogen Corp., of San Diego, Calif., licensed from Cell Genesys Inc., of Foster City, Calif., its lentiviral gene delivery technology for commercialization in the research market. Under the licensing agreement, Invitrogen¿s customers will be able to perform gene expression research and drug-target validation in non-dividing or slowly dividing cell types. Cell Genesys will receive royalties on sales and a share of any sublicense payments.
¿ NeoTherapeutics Inc., of Irvine, Calif., reached an agreement to repurchase $5 million of convertible preferred stock in its NeoGene Technologies Inc. subsidiary from two institutional investors. The shares were issued on Sept. 21, 2001, and gave the investors the option to exchange their NeoGene preferred stock into NeoTherapeutics preferred stock and then convert to NeoTherapeutics common stock, based on the market price of the company¿s stock prior to conversion.
¿ Oncology Sciences Corp., of Austin, Texas, published findings that 2-methoxyestradiol (2-ME) inhibits the growth of human prostate cancer cells. The research was sponsored by OSC and conducted by Addanki Kumar of the AMC Cancer Research Center of Denver. An article describing the research was published in the July issue of Molecular Carcinogenesis.
¿ Paradigm Genetics Inc., of Research Triangle Park, N.C., said it has processed more than 1 million Arabidopsis thaliana plants through its GeneFunction Factory. The GeneFunction Factory explores the function of the genes by integrating sequencing technology with phenotype, metabolite and gene expression profiling.
¿ Physiome Sciences Inc., of Princeton, N.J., launched the PathwayPrism technology platform at IBC Drug Discovery Technology 2001 conference in Boston. The technology is designed to visualize, integrate, simulate and annotate molecular interactions in cell signaling. Separately, Physiome said it reached an agreement in which it will use IBM¿s next-generation supercomputing technology for research on biological systems, diseases and potential drug targets. Also, IBM will license biological modeling technology from Physiome for its internal use. Financial terms were not disclosed.
¿ Solvay Pharmaceuticals BV, of Brussels, Belgium, sublicensed from BioSante Pharmaceuticals, of Lincolnshire, Ill., U.S. and Canadian rights to an estrogen/progestogen combination transdermal hormone replacement gel product. With the agreement Solvay now holds worldwide rights to the product, excluding Japan and Korea. The agreement involves an initial payment of $2.5 million, future milestone payments and sales-based royalties. The product is being developed for the treatment of non-hysterectomized, menopausal women suffering from hot flashes and other menopausal symptoms.